The Study Of Pharmaceutical Test Data Protection In TPP Agreement

TRIPS Agreement initially established an international protection of pharmaceutical test data. However, subject to the multiple interest conflicts and complexity of negotiating power, the final result left certain flexibility which allows developing countries to decide the level of protection when incorporating and implementing such standards into domestic legislature. It did not conform to the approaches by the developed countries to protect their superior market power in innovative drug industry. In the years since the TRIPS Agreement entered into force, the U.S. continued taking the data exclusivity issue back to the FTA negotiation table and successfully pushed the partners towards TRIPS-Plus standards. The final concluded version of TPP shows a brand new stringent IP packages. This article explores an appropriate step for China confronted by the new challenges of high TPP standards in compare with the domestic legal rules and international obligation and also tries an in-depth discussion on the legal status of pharmaceutical test data.Followed by a brief introduction of issues and the necessity of this research, this article narrates the discussion with five parts. The first part discusses theoretical issues on the pharmaceutical test data including its definition, origins and purpose as well as the legal status of data exclusivity. The study finds that the data protection plays an alternative and supplemental role beyond the traditional patent protection which challenges a well-accepted standpoint regarding data exclusivity as an independent intellectual property right. This article reframes data exclusivity as an administrative lock-up period before the law allows second market entrant with an abbreviated application without full support of independent test data. But this article also confirms the IP nature of test data per se. The second part, in light of the theoretical basis discussed in the first part, goes on to review the ongoing domestic rules and international standards and examines the cause and effect of different data protection. The third part introduces the final TPP standards and analyses the relationships between TPP standards and other existing data protection scheme from comparative perspective. The forth part discussion focuses on the domestic rules in China using the insights of the prior section to explore how the legal rules benefit both the innovation and the social benefit considering the overall market situation and R&D capability of domestic pharmaceutical enterprises. The fifth part gives a brief summary of the whole article.The goal of this article is to orient scholars and policymakers a different approach to understand data exclusivity and ultimately recommend a practical way to cope with a new high-protection trend formed by TPP.